Ocular-vestibular Biomarker Identification for ADHD

• Sponsor: Sync-Think, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04504890
• Collaborator: Sutter Health (Other)
• Enrollment: 240
• Location: 1
• Anticipated Duration (Months): 14.7
• Patients Per Site Per Month: 16.4

Study Details

Study Description

Brief Summary

This study intends to establish a relationship between oculovestibular eye tracking measures, measures of ADHD, and medication prescribed for ADHD.

Condition or Disease	Intervention/Treatment	Phase
ADHD - Combined Type; ADHD; ADHD Predominantly Inattentive Type; ADHD, Predominantly Hyperactive - Impulsive	Device: EYE-SYNC

Detailed Description

This study will use a predictive visual tracking paradigm (SyncThink EYE-SYNC eye tracking paradigm) to dynamically capture the participants' attentional state. It will examine the validity of the eye tracking paradigm in identifying the disruption in attentional networks caused by ADHD by examining the association between eye tracking performances and well-established standardized measures of ADHD.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 240 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Ocular-vestibular Biomarker Identification for ADHD
• Actual Study Start Date: Jul 16, 2020
• Anticipated Primary Completion Date: Aug 5, 2021
• Anticipated Study Completion Date: Oct 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Adults - Diagnosis Adults seeking treatment for an attention-related disorder	Device: EYE-SYNC; Nystagmograph used to measure eye movement
Adults - Prescribed Adults who have been diagnosed with ADHD and prescribed medication treatment for the disorder	Device: EYE-SYNC; Nystagmograph used to measure eye movement
Children - Diagnosis Children seeking treatment for an attention-related disorder	Device: EYE-SYNC; Nystagmograph used to measure eye movement
Children - Prescribed Children who have been diagnosed with ADHD and prescribed medication treatment for the disorder	Device: EYE-SYNC; Nystagmograph used to measure eye movement

Outcome Measures

Primary Outcome Measures

1. Eye Tracking and ADHD measure correlation [through study completion, an average of 1 year]

   Zero-order correlations among eye tracking parameters, CAARS ADHD indices, CBRS ADHD indices, and confounding variables

2. Eye Tracking ADHD Diagnostic ROC [through study completion, an average of 1 year]

   Specific eye tracking parameters will be compared to determine which have the greatest diagnostic utility. Supervised machine learning models will be generated and optimized ROC AUC for both children and adults using eye tracking parameters as input and CAARS indices, CBRS indices, and clinical diagnosis as outcomes

3. MANCOVA Eye Tracking in ADHD Treatment Population [through study completion, an average of 1 year]

   Repeated measures multivariate analysis of covariance (MANCOVA) will be used to compare eye tracking performance over time in adults and children with ADHD (medicated and unmedicated)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Men and women ages 6-70 seeking evaluation and treatment for ADHD.

Exclusion Criteria:

• Clinical diagnosis of a neurological condition including the following: stroke, multiple sclerosis, epilepsy, brain tumor/cancer, dyslexia, nystagmus and/or other major neurological condition.

• Clinical diagnosis of any of the following eye-sight abnormalities: uncorrected amblyopia, uncorrected myopia, uncorrected presbyopia, uncorrected farsightedness or uncorrected Astigmatism.

• Psychiatric history with any of the following:

• LIFETIME: Clinical diagnosis of a psychotic disorder; bipolar disorder

• LAST YEAR: Clinical diagnosis of major depressive disorder; PTSD; clinical diagnosis of substance abuse disorder; major anxiety disorder

• Use of a psychotropic medication

• Impairment of cranial nerves II-VI

• Participants who receive a 'Poor' or 'Fair' eye tracking quality result on either their baseline or follow-up evaluations will be excluded from analysis. Subjects may not repeat participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palo Alto Medical Foundation - San Carlos Center	San Carlos	California	United States	94070

Sponsors and Collaborators

• Sync-Think, Inc.
• Sutter Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sync-Think, Inc.
• ClinicalTrials.gov Identifier: NCT04504890
• Other Study ID Numbers: EYESYNCOBIADHD2020
• First Posted: Aug 7, 2020
• Last Update Posted: Oct 23, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Sync-Think, Inc.: ADHD; EYE-SYNC; eye tracking; oculomotor; vestibular
• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Oct 23, 2020